Back to resultsPhysiotherapy in the Reduction of Post-needling Soreness
Primary Purpose
Dry Needling, Soreness, Muscle, Trigger Point Pain, Myofascial
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Concentric contraction exercise
Isometric contraction exercise
Eccentric contraction exercise
Analytic passive stretching
Sponsored by
About this trial
This is an interventional treatment trial for Dry Needling
Eligibility Criteria
Inclusion Criteria:
- Age between 18 and 65 years;
- Cervical pain.
- Presence of an active PGM in the upper trapezius muscle.
Exclusion Criteria:
- Traumatic history in the cervical region;
- Inability to understand or perform the required exercises;
- Pregnancy in the first trimester;
- Altered state of coagulation;
- Immunosuppression status;
- State of alteration of sensitivity (e.g. central sensitization processes, fibromyalgia, etc.);
- Unavoidable fear of needles;
- Lack of knowledge about the use of the WhatsApp or Telegram messaging platform
Sites / Locations
- Clinical University Physiotherapy and pain
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Concentric contraction exercise
Isometric contraction exercise
Eccentric contraction exercise
Analytic passive stretching.
Arm Description
After applying the dry needling technique to the upper trapezius muscle, the participant will be placed in a standing position, with the shoulders positioned in the scapular plane. A medium stiffness Theraband elastic band will be placed between the participant's ipsilateral foot on the side on which the dry needling technique was applied and the acromio-clavicular joint on the same side.The exercise will consist of raising the shoulder against the resistance of the elastic band, slowly and for 5 seconds
After applying the dry needling technique to the upper trapezius muscle, the participant will be placed in a standing position, with the shoulders positioned in the scapular plane. A medium stiffness Theraband elastic band will be placed between the participant's ipsilateral foot on the side on which the dry needling technique was applied and the acromio-clavicular joint on the same side.The exercise will consist of raising the shoulder and maintaining the tension of the elastic band for 5 seconds
After applying the dry needling technique to the upper trapezius muscle, the participant will be placed in a standing position, with the shoulders positioned in the scapular plane. A medium stiffness Theraband elastic band will be placed between the participant's ipsilateral foot on the side on which the dry needling technique was applied and the acromio-clavicular joint on the same side.The exercise will consist of raising the shoulder against the resistance of the elastic band, slowly and for 5 seconds
After applying the dry needling technique to the upper trapezius muscle, the patient remains supine position. The analytical passive stretch of the upper trapezius will be performed only once, bringing the muscle to the limit of elastic tension perceived by the subject. The passive stretching technique will be held for 30 seconds.
Outcomes
Primary Outcome Measures
Post-needling soreness intensity
The investigators use a Visual Analog Scale (VAS) to determine the intensity of the patient's post-needing pain after and for 72 hours after DN.The VAS is a 100-mm line, oriented horizontally, with one end representing "no pain" and the other end representing "worst pain." Subjects will be asked to rate their current pain with a mark on the scale.
Secondary Outcome Measures
Pain Catastrophizing
This scale is a Likert-type questionnaire with 5 levels (0-4) that includes 13 items that measure 3 dimensions of catastrophism: magnification, rumination and despair. The Spanish version of this scale has shown to have an appropriate internal consistency, test-retest reliability and sensitivity to changes.
Fear of Pain.
Fear of Pain Questionnaire. This scale is a Likert-type questionnaire with 5 levels (1-5) with 3 lists of 10 sub-items that contemplate 3 different aspects of fear of pain: fear of mild pain, fear of severe pain, fear of pain related to the area doctor. The Spanish version of this scale has shown to have an acceptable validity and reliability.
Pain Anxiety Symptoms
The Pain Anxiety Symptoms Scale. This Likert-type questionnaire with 6 levels (0-5) includes 20 items that measure 4 dimensions of pain anxiety: cognitive anxiety, escape / avoidance, fear and physiological anxiety. The Spanish version of this scale has been shown to have appropriate validity and reliability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04695548
Brief Title
Physiotherapy in the Reduction of Post-needling Soreness
Official Title
Comparison of Isometric, Concentric, Eccentric Exercise and Passive Stretching in the Reduction of Post-needling Soreness in Patients With Cranial and/or Cervical Pain Related to Myofascial Pain
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
February 23, 2021 (Actual)
Primary Completion Date
April 25, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alcala
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Dry needling is a minimally invasive technique which generates good results and neuromuscular benefits. Its application involves a highly prevalent effect called post-needling soreness. It is defined as a residual pain, located in the incision area, with a self-limiting period of 24-72 hours, as a result of a physiological process generated by the technique.
So far, different clinical trials have been carried out to measure the effectiveness of several techniques for reducing post-needling soreness, reaching positive results. However, no studies have been found with the aim of distinguish which method is more effective for this goal; therefore, it is clear the need to continue investigating on the subject and comparing these techniques among them.
Detailed Description
Main objective. To figure out if one of the four techniques (isometric, concentric, eccentric contraction exercise and analytic passive stretching) is more effective for reducing post- needling soreness immediately, at 12, 24, 48 and 72 hours.
Objectives. To verify if there is a correlation between independent variables and post-needling soreness.
Study type. Non-blinded randomized clinical trial. Intervention. Dry needling on an active myofascial trigger point in superior trapezius, followed by one of the following treatments according to the specific group: 1) concentric contraction exercise, 2) isometric contraction exercise, 3) eccentric contraction exercise or 4) analytic passive stretching.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Needling, Soreness, Muscle, Trigger Point Pain, Myofascial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Concentric contraction exercise
Arm Type
Experimental
Arm Description
After applying the dry needling technique to the upper trapezius muscle, the participant will be placed in a standing position, with the shoulders positioned in the scapular plane. A medium stiffness Theraband elastic band will be placed between the participant's ipsilateral foot on the side on which the dry needling technique was applied and the acromio-clavicular joint on the same side.The exercise will consist of raising the shoulder against the resistance of the elastic band, slowly and for 5 seconds
Arm Title
Isometric contraction exercise
Arm Type
Experimental
Arm Description
After applying the dry needling technique to the upper trapezius muscle, the participant will be placed in a standing position, with the shoulders positioned in the scapular plane. A medium stiffness Theraband elastic band will be placed between the participant's ipsilateral foot on the side on which the dry needling technique was applied and the acromio-clavicular joint on the same side.The exercise will consist of raising the shoulder and maintaining the tension of the elastic band for 5 seconds
Arm Title
Eccentric contraction exercise
Arm Type
Experimental
Arm Description
After applying the dry needling technique to the upper trapezius muscle, the participant will be placed in a standing position, with the shoulders positioned in the scapular plane. A medium stiffness Theraband elastic band will be placed between the participant's ipsilateral foot on the side on which the dry needling technique was applied and the acromio-clavicular joint on the same side.The exercise will consist of raising the shoulder against the resistance of the elastic band, slowly and for 5 seconds
Arm Title
Analytic passive stretching.
Arm Type
Experimental
Arm Description
After applying the dry needling technique to the upper trapezius muscle, the patient remains supine position. The analytical passive stretch of the upper trapezius will be performed only once, bringing the muscle to the limit of elastic tension perceived by the subject. The passive stretching technique will be held for 30 seconds.
Intervention Type
Other
Intervention Name(s)
Concentric contraction exercise
Other Intervention Name(s)
Muscle concentric contraction
Intervention Description
The participant will be placed in a standing position, with the shoulders positioned in the scapular plane. A medium stiffness Theraband elastic band will be placed between the participant's ipsilateral foot on the side on which the dry needling technique was applied and the acromio-clavicular joint on the same side.The exercise will consist of raising the shoulder against the resistance of the elastic band, slowly and for 5 seconds
Intervention Type
Other
Intervention Name(s)
Isometric contraction exercise
Other Intervention Name(s)
Muscle isometric contraction
Intervention Description
The participant will be placed in a standing position, with the shoulders positioned in the scapular plane. A medium stiffness Theraband elastic band will be placed between the participant's ipsilateral foot on the side on which the dry needling technique was applied and the acromio-clavicular joint on the same side.The exercise will consist of raising the shoulder and maintaining the tension of the elastic band for 5 seconds
Intervention Type
Other
Intervention Name(s)
Eccentric contraction exercise
Other Intervention Name(s)
Muscle eccentric contraction
Intervention Description
The participant will be placed in a standing position, with the shoulders positioned in the scapular plane. A medium stiffness Theraband elastic band will be placed between the participant's ipsilateral foot on the side on which the dry needling technique was applied and the acromio-clavicular joint on the same side.The exercise will consist of asking the participant to lower their shoulder, against the resistance of the elastic band, in a slow and controlled manner for 5 seconds.
Intervention Type
Other
Intervention Name(s)
Analytic passive stretching
Other Intervention Name(s)
Muscle passive stretching
Intervention Description
The patient remains supine position. The analytical passive stretch of the upper trapezius will be performed only once, bringing the muscle to the limit of elastic tension perceived by the subject. The passive stretching technique will be held for 30 seconds.
Primary Outcome Measure Information:
Title
Post-needling soreness intensity
Description
The investigators use a Visual Analog Scale (VAS) to determine the intensity of the patient's post-needing pain after and for 72 hours after DN.The VAS is a 100-mm line, oriented horizontally, with one end representing "no pain" and the other end representing "worst pain." Subjects will be asked to rate their current pain with a mark on the scale.
Time Frame
Change From Baseline in Pain Scores on the Visual Analog Scale at 72 hours.
Secondary Outcome Measure Information:
Title
Pain Catastrophizing
Description
This scale is a Likert-type questionnaire with 5 levels (0-4) that includes 13 items that measure 3 dimensions of catastrophism: magnification, rumination and despair. The Spanish version of this scale has shown to have an appropriate internal consistency, test-retest reliability and sensitivity to changes.
Time Frame
Change from Baseline Pain Catastrophizing at 72 hours.
Title
Fear of Pain.
Description
Fear of Pain Questionnaire. This scale is a Likert-type questionnaire with 5 levels (1-5) with 3 lists of 10 sub-items that contemplate 3 different aspects of fear of pain: fear of mild pain, fear of severe pain, fear of pain related to the area doctor. The Spanish version of this scale has shown to have an acceptable validity and reliability.
Time Frame
Change from Baseline Fear of Pain at 72 hours.
Title
Pain Anxiety Symptoms
Description
The Pain Anxiety Symptoms Scale. This Likert-type questionnaire with 6 levels (0-5) includes 20 items that measure 4 dimensions of pain anxiety: cognitive anxiety, escape / avoidance, fear and physiological anxiety. The Spanish version of this scale has been shown to have appropriate validity and reliability
Time Frame
Change from Baseline Pain Anxiety at 72 hours.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 18 and 65 years;
Cervical pain.
Presence of an active PGM in the upper trapezius muscle.
Exclusion Criteria:
Traumatic history in the cervical region;
Inability to understand or perform the required exercises;
Pregnancy in the first trimester;
Altered state of coagulation;
Immunosuppression status;
State of alteration of sensitivity (e.g. central sensitization processes, fibromyalgia, etc.);
Unavoidable fear of needles;
Lack of knowledge about the use of the WhatsApp or Telegram messaging platform
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Pecos-Martin, PhD
Organizational Affiliation
Alcala University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical University Physiotherapy and pain
City
Alcala de Henares
State/Province
Madrid
ZIP/Postal Code
2805
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Physiotherapy in the Reduction of Post-needling Soreness
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